Cleared Special

Spine & Trauma Navigation Instruments

K252562 · Brainlab AG · Orthopedic
Sep 2025
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K252562 is an FDA 510(k) clearance for the Spine & Trauma Navigation Instruments, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Brainlab AG (Munich, DE). The FDA issued a Cleared decision on September 12, 2025, 29 days after receiving the submission on August 14, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K252562 FDA.gov
FDA Decision Cleared SESE
Date Received August 14, 2025
Decision Date September 12, 2025
Days to Decision 29 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code OLO — Orthopedic Stereotaxic Instrument
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4560
Definition Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw.

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